FDA approves Qulipta as preventive migraine treatment

The FDA has approved Qulipta for the prevention of migraine.

“Millions of people living with migraine often lose days of productivity each month because attacks can be debilitating,” Michael Severino, MD, vice chair and president of AbbVie, the manufacturer of the drug, said in a press release. “Qulipta [atogepant, AbbVie] can help by reducing monthly migraine days with a once-daily, oral dose that works quickly and continuously.”

The FDA supported its approval using data from a clinical program that evaluated the efficacy, safety and tolerability of atogepant among approximately 2,000 patients with four to 14 migraines per month. Studies included the pivotal phase 3 ADVANCE study, the pivotal phase 2b/3 study and the phase 3 long-term safety study. Key support included all atogepant dose groups in the ADVANCE study having met the primary end point of change from baseline in mean monthly migraine days across the 12-week treatment period and all doses being well tolerated in the ADVANCE trial and the pivotal phase 2b/3 clinical trial. Adverse events (incidence of 2% or greater than placebo) in both studies included nausea, constipation, fatigue/somnolence and decreased appetite.

"We are proud that AbbVie is now the only pharmaceutical company to offer three products across the full spectrum of migraine treatment, which include preventive therapies for chronic and episodic migraine and an acute treatment for migraine attack,” Severino said in the release.